Embolus blood clot filter removal system and method

ABSTRACT

A blood filter extraction system for extracting a blood filter from within a blood vessel. The system includes an extraction wire, or plurality of such wires, positioned within an elongated tubular member. A plurality of extraction wires coupled to the distal end of the extraction member each include a hook for engaging filter members. Alternatively, the extraction wires may be one or more wires configured in a helical shape which engage filter members when the extraction member is rotated. The system may also include an elongated tubular member with the distal end having a conical shape. To extract a filter, the extraction wires are then pushed out of the tubular member and into the filter members. The extraction member is then withdrawn or rotated so the wires engage and draw in the filter members, after which the catheter is pushed over the conical portion of the tubular member.

PRIORITY DATA AND INCORPORATION BY REFERENCE

This application claims benefit of priority to U.S. Provisional PatentApplication No. 60/754,598, filed Dec. 30, 2005 which is incorporated byreference in its entirety. This invention is related to the subjectmatter shown and described in the following: (i) PCT InternationalApplication No. ______, filed Dec. 29, 2006, having Attorney Docket No.14673-007WO, entitled “Removable Blood Clot Filter with Edge For CuttingThrough the Endothelium” and claiming the benefit of priority to U.S.Provisional Patent Application No. 60/754,600, filed Dec. 30, 2005; (ii)PCT International Application No. ______, filed Dec. 29, 2006, havingAttorney Docket No. 14673-004WO, entitled “Embolus Blood Clot Filterwith Post Delivery Actuation,” and claiming the benefit of priority toU.S. Provisional Patent Application No. 60/754,633, filed Dec. 30, 2005;(iii) PCT International Application No. ______, filed Dec. 29, 2006,having Attorney Docket No. 14673-008WO, entitled “Embolus Blood ClotFilter Delivery System,” and claiming the benefit of priority to U.S.Provisional Patent Application No. 60/754,636, filed Dec. 30, 2005; (iv)PCT International Application No. ______, filed Dec. 29, 2006, havingAttorney Docket No. 14673-005WO, entitled “Embolus Blood Clot Filterwith Floating Filter Basket,” and claiming the benefit of priority toU.S. Provisional Patent Application No. 60/754,599, filed Dec. 30, 2005;and (v) PCT International Application No. ______, filed Dec. 29, 2006,having Attorney Docket No. 14673-010WO, entitled “Embolus Blood ClotFilter with Bio-Resorbable Coated Filter Members,” and claiming thebenefit of priority to U.S. Provisional Patent Application No.60/754,597, entitled “Embolus Blood Clot Filter with Retainers onLocator Filter Members,” filed Dec. 30, 2005, each of which is herebyincorporated by reference in its entirety.

TECHNICAL FIELD

This invention relates to a medical apparatus for removing filterdevices from a vessel of a mammalian body, and more particularly for acatheter-born blood filter extraction apparatus and methods of using it.

BACKGROUND ART

In recent years, a number of medical devices have been designed whichare adapted for compression into a small size to facilitate introductioninto a vascular passageway and which are subsequently expandable intocontact with the walls of the passageway. These devices include, amongothers, blood clot filters which expand and are held in position byengagement with the inner wall of a vein, such as the vena cava. Venacava filters are known in the art as described, for example, in U.S.Pat. Nos. 4,425,908, 5,669,933 and 5,836,968 and European Patent Officepublication 0 188 927 A2, which are hereby incorporated by reference intheir entireties. These vena cava filters are generally designed toremain in place permanently. Such filters include structure to anchorthe filter within the vena cava, such as elongate diverging anchormembers with hooked ends that penetrate the vessel wall and positivelyprevent longitudinal migration in either direction within the vessel.The hooks on filters of this type are rigid and will not bend, andwithin two to six weeks after a filter of this type has been implanted,the endothelium layer grows over the diverging anchor members andpositively locks the hooks in place. Any attempt to remove the filterthereafter risks injury to or rupture of the vena cava. Nevertheless, anumber of vena cava filters have been fitted with a hook on the hub thatcan be snared and used to pull the filter into a catheter for removal,an example of which is disclosed in U.S. Pat. No. 5,836,968, which ishereby incorporated by reference in its entirety.

Most existing filters, including filters currently present in patients,are not configured to be removable or fitted with an extraction hook andtheir configurations render them difficult or potentially dangerous toremove. In addition to the challenge of disengaging the filter membersfrom the endothelium without rupturing the blood vessel, there is thedifficulty of locating and acquiring the filter so that it can bewithdrawn from the vessel into an intravenal catheter. Accordingly,there is a need for an apparatus that can safely locate, capture andremove a blood filter from a patient without the need for major surgery.

DISCLOSURE OF INVENTION

An apparatus for removing a blood filter from a blood vessel includes anelongate extraction member configured to be positioned within the lumenof a catheter and to move longitudinally and rotationally with respectto the catheter. The extraction member includes a plurality of wirescoupled to its distal end with a hook coupled to each of the pluralityof wires. The extraction member may be positioned within an elongatedtubular member, which includes a conical portion on the distal end.Alternatively, a conical portion may be coupled to the extractionmember.

Another embodiment of an apparatus for removing a blood filter from ablood vessel includes an elongated extraction member configured to bepositioned within the lumen of a catheter and to move longitudinally androtationally with respect to the catheter. The elongated extractionmember preferably includes a first extraction wire coupled to its distalend. The first extraction wire may be configured as a helix and coupledto the distal end of the elongated extraction member. The extractionmember may also include a second helical extraction wire coupled to thedistal end of the extraction member.

A method for removing a filter from a blood vessel having a plurality offilter members including at least some of the steps of positioning acatheter in the blood vessel so a distal end of the catheter is proximalto the filter; inserting a tubular member into the catheter; positioningthe tubular member in the catheter so the conical member extends fromthe distal end of the catheter and passes over a portion of the filter;inserting an extraction member into the tubular member, the extractionmember includes a plurality of wires each of which includes a hook;pushing the extraction member within the tubular member in a distaldirection until the plurality of wires extend beyond the distal end ofthe catheter and contact the filter members; pulling the extractionmember in a proximal direction while not moving the catheter or thetubular member such that the filter members move toward the centerline;positioning the tubular member so the conical member contacts a portionof the filter; pushing the catheter in a distal direction without movingthe tubular member to cause the catheter to collapse the conical memberover at least a portion of the filter; drawing the filter and tubularmember into the catheter; and removing the catheter from the patient.

A method for removing a filter from a blood vessel having a plurality offilter members including at least some of the steps of positioning acatheter in the blood vessel so a distal end of the catheter is proximalto the filter; inserting an extraction member into the tubular member,the extraction member including a helical extraction wire on the distalend; positioning the helical extraction wire over a portion of thefilter; rotating the extraction member to cause the helical extractionwire to engage filter; drawing the filter into the catheter; andremoving the catheter from the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate various embodiments of theinvention, and, together with the general description given above andthe detailed description given below, explain features of the invention.

FIG. 1 is a perspective view of a blood filter.

FIG. 2 is a side view of a catheter suitable for use with an embodimentfilter extraction system.

FIG. 3 is a side perspective view of a tubular member that preferablyforms part of an embodiment filter extraction system.

FIG. 4 is a side perspective of a filter extraction member thatpreferably forms part of an embodiment filter extraction system.

FIG. 5A through 5E are detail perspective views of hooking or snaringelements of the extraction member illustrated in FIG. 4.

FIG. 6 is a side perspective view of an embodiment of the filterextraction system at a stage of deployment prior to engaging a filter.

FIGS. 7A and 7B are side perspective views of an embodiment of thefilter extraction system at later stages of deployment than thatillustrated in FIG. 6.

FIG. 8 illustrates the positioning of the catheter shown in FIG. 2 neara filter within a blood vessel.

FIG. 9 illustrates a step in the process of extracting a blood filterfrom a blood vessel according to an embodiment.

FIGS. 10A and 10B illustrate subsequent steps in the process ofextracting a blood filter from a blood vessel according to anembodiment.

FIGS. 11A and 11B illustrate a further step in the process of extractinga blood filter from a blood vessel according to an embodiment.

FIG. 12 illustrates a still further step in the process of extracting ablood filter from a blood vessel according to an embodiment.

FIG. 13 is a side perspective of a filter extraction member of analternative embodiment filter extraction system.

FIG. 14 is a side perspective of a filter extraction member of analternative embodiment filter extraction system.

FIG. 15 illustrates an alternative embodiment of the filter extractionsystem.

FIG. 16 illustrates a step in the process of extracting a blood filterfrom a blood vessel according to the extraction system embodimentillustrated in FIG. 13.

FIG. 17 illustrates a subsequent step in the process of retracting ablood filter from a blood vessel according to the extraction systemembodiment illustrated in FIG. 13.

FIG. 18 illustrates a further step in the process of retracting a bloodfilter from a blood vessel according to the extraction system embodimentillustrated in FIG. 13.

FIGS. 19A and 19B illustrate alternative embodiments of the filterextraction member.

MODE(S) FOR CARRYING OUT THE INVENTION

The accompanying drawings and description represent the preferredembodiments of the invention. Wherever possible, the same referencenumbers will be used throughout the drawings to refer to the same orlike parts.

As used herein, the terms “about” or “approximately” for any numericalvalues or ranges indicate a suitable dimensional tolerance that allowsthe part or collection of components to function for its intendedpurpose as described herein. Also, as used herein, the terms “patient,”“host” and “subject” refer to any human or animal subject and are notintended to limit the systems or methods to human use, although use ofthe subject invention in a human patient represents a preferredembodiment. Moreover, as used herein, the term “wire” refers to anyelongated member of narrow cross section, including rods, bars, tubes,ribbon and narrow sections cut from thin plate, and is not intended tolimit the scope of the invention to elongated members of circular crosssection, cut from wire stock or manufactured according to a particularmethod of metal forming.

The various embodiments of the blood filter extraction system areconfigured to engage and retract a typical blood filter from within apatient's blood vessel, such as the vena cava. A preferred blood filter1 is illustrated in FIG. 1. Typically, a blood filter includes a numberof filter members (e.g., wires) which both position and anchor thefilter within a blood vessel and serve as the filtering elements whichcatch and retain blood clots in the blood.

Referring to FIG. 1, a filter 1 may include a plurality of anchormembers 30 which are positioned radially around the filter 1 and includehooks 40 which hook into the blood vessel wall to secure the filterwithin the vessel. A filter 1 may also include locator members 20positioned radially around the filter and configured to press radiallyoutward against the blood vessel wall to center the filter within thevessel. A filter 1 may also include a hub 2 to which the locator members20 and anchor members 30 are attached, such as by welding. When deployedwithin a blood vessel, the anchor members 30 preferably form a firstconical filter basket while the locator members 20 further preferablyform a second filter basket positioned downstream from the first filterbasket. The hooks 40 may be configured to have a reduced cross sectioncompared to the rest of the anchor or locator members. By reducing thecross sectional area of a portion or all of the hooks 40 relative tothat of the anchor members 30 or locator members 20, stress will beconcentrated in the areas of reduced cross section when longitudinalforce is applied to the hub 2 in the direction of blood flow BF (i.e.,towards the hub 2 of the filter) such as to remove the filter. Furtherdescription of blood filter configurations and constructions areprovided in U.S. Pat. No. 6,258,026, and PCT International ApplicationNo. PCT/US06/017889, entitled “Removable Embolus Blood Clot Filter,”filed May 9, 2006, both of which are hereby incorporated by reference intheir entireties. Also, descriptions of systems and methods used forimplanting a filter in a blood vessel are provided in PCT InternationalApplication No. PCT/US06/17890, entitled “Embolus Blood Clot Filter andDelivery System,” filed on May 9, 2006, which is also herebyincorporated by reference in its entirety.

When a filter 1, such as that illustrated in FIG. 1, has been in placewithin a blood vessel for a few weeks, the endothelial layer will tendto grow over the portions of the anchors 30, in particular the hooks 40,and the locator members 20 in contact with the vessel wall. Thisendothelial overgrowth helps to hold the filter 1 in position, but maycreate difficulties for extraction procedures. To avoid this, it ispreferable to depress the filter members 20, 30 (i.e., anchors andlocators) toward the vessel centerline before the filter is movedlongitudinally through the vessel. Accordingly, preferred embodiments ofthe blood filter extraction system first engage the filter members withan extraction wire and then radially collapse the filter members awayfrom the vessel walls and into a catheter before the catheter iswithdrawn from the blood vessel.

One preferred embodiment of the blood filter extraction system includesan extraction member (embodiments of which are illustrated in FIGS. 4,13 and 14), which is preferably configured to be delivered to thevicinity of the filter 1 by a catheter 50 (illustrated in FIG. 2). Insome embodiments, an elongated tubular member (illustrated in FIG. 3)featuring a conical distal end is also used to help collapse the filtermembers when the catheter is pressed over the conical end.

The filter extraction system uses a catheter to gain access to thefilter within a vessel and withdraw it from the patient's body. Astandard medical catheter of about 7 to 10 French diameter may be used.In an embodiment illustrated in FIG. 2, a catheter 50 is provided aspart of the filter extraction system that includes elements whichfacilitate the filter extraction process. Referring to FIG. 2, thecatheter 50 has a diameter D1 which may be that of a 7 to 10 Frenchdiameter catheter, though larger and smaller catheters may also be used.The catheter 50 features an exterior surface 51 and an internal surface52 defining an internal lumen 53. The catheter 50 is preferably about 45inches long, although longer and shorter catheters may be used dependingupon the size of the patient, the location of the blood filter to beextracted and the particular point of entry into the body to be used.

The catheter 50 may also include one or more radio-opaque markers 54 and55 that can be easily imaged by radiography or fluoroscopy to permit aclinician to accurately determine the position of the catheter within apatient's body. In the embodiment illustrated in FIG. 2, tworadio-opaque markers 54 and 55 are used, the first circumferentialmarker 54 located close to the distal end of the catheter 50, at lengthL1 from the end, and a second circumferential marker 55 located lengthL2 from the first marker 54. In a preferred embodiment, length L1 rangesfrom approximately 0.01 inch to approximately 0.5 inch, and length L2ranges from approximately 0.5 inch to approximately 2 inches. As usedherein, a radio-opaque marker is any material that is identifiable tomachine or human-readable radiographic equipment while the material isinside a mammal body, such as, by way of example but not by way oflimitation, gold, platinum, barium sulfate, or tantalum. The use of onemarker allows a clinician to determine the location of a retrievingcatheter tip. But two radio-opaque markers located a known distanceapart can be utilized to allow the clinician to locate a deliverycatheter within a blood vessel of the patient and accurately estimatethe distance between the catheter's distal end and a filter. Forexample, the distance L2 between the first 54 and second 55 markers canbe used as a distance scale when the filter and catheter are both imagedby fluoroscopy. To facilitate locating the catheter near the filter, thefilter hub 2 can include a radio-opaque marker, such as by including aradio-opaque element in the hub material or coupling a radio-opaquemarker to or within the hub 2.

In use, the catheter 50 may be introduced into a patient via an incisioninto a major vein, such as the jugular vein, or artery, such as thefemoral artery, and advanced through the blood vessel 10 to the vicinityof the filter 1, as illustrated in FIG. 8. As mentioned above, theclinician may use fluoroscopy to confirm that the catheter 50 ispositioned at a proper distance away from the filter 1. In thisposition, a clinician may advance an ultrasound imager (not shown) or afiber optic imager (not shown) through the catheter 50 to inspect thefilter to determine if extraction is required or to inspect the filterin preparation for extraction. Saline solution may be provided throughthe catheter 50 to displace blood in order to facilitate imaging by afiber optic imager.

The catheter may be formed of any materials used for medical catheters,including by way of example polyurethane, polyethylene, polyamide,polyether block amide (PEBA), nylon, and combinations thereof.

In an embodiment illustrated in FIG. 3, an elongated tubular member 60may be advanced through the catheter 50 to the vicinity of the filter.Alternatively, the elongated tubular member 60 may be positioned withinthe catheter 50 when the catheter is introduced into the patient. Thetubular member 60 has a diameter D2, which is preferably slightlysmaller than the internal diameter of the catheter 50 in which it is tobe inserted. The tubular member 60 has an exterior surface 61 and aninterior surface 62 defining an internal lumen 63, and a conical portion66 defined by a radius R2 at the distal end 67. The tubular member 60 ispreferably longer than the catheter 50 so that it can be manipulated bythe clinician from the proximal end extending out of the catheter 50. Inan embodiment, the tubular member may include radio-opaque markers 64,65, located, for example, near the distal end 67 (markers 64) and adistance L3 from the distal end 67 (markers 65). The radio-opaquemarkers 64, 65 may be separated by a known distance L4 to facilitatedetermining the position of the conical end 66 with respect to thefilter using fluoroscopy. In various embodiments, the radius R2 mayrange from approximately 0.25 inches to approximately 0.75 inches, thedistance L4 may range from between approximately 0.01 inch andapproximately 0.25 inch, and distance L3 may range from betweenapproximately 0.5 inch and approximately 2 inches.

In order to permit the conical portion 66 to fit within the catheter 50,the tubular member 60 may include folds 68, which may be strips or zonesof reduced thickness, along which the conical portion 66 preferentiallyfolds or collapses. Radio-opaque markers 64 near the distal end 67 maybe provided in arc segments as illustrated so that when the conicalportion 66 is positioned within the catheter 50 the portions form anapproximately continuous circumferential marker.

The tubular member may be formed of any materials used for medicalcatheters, including by way of example polyurethane, polyethylene,polyamide, polyether block amide (PEBA), nylon, and combinationsthereof.

FIG. 4 illustrates an embodiment of the extraction member 70. Anextraction member 70 has a long wire or rod 71 which will be longer thanthe catheter 50 and the tubular member 60 so that it can be manipulatedby a clinician when in place. A handle may be provided on a proximal endto facilitate manipulation of the extraction member 70 by a clinician. Atransition plug or hub 72 may be positioned at or near the distal end ofthe extraction member rod 71. This plug or hub 72 is coupled, such as bywelding, brazing or swaging, to a plurality of extraction wires 73extending therefrom in a distal direction. Each of the plurality ofwires 73 may be tipped with a coupler 74 which is further preferablyconfigured as a bend, loop or hook. The plurality of wires 73 may be ofthe same or different lengths preferably ranging from approximately 0.5inch to approximately 1.5 inch, and may be configured to bend away fromthe centerline of the extraction member 70 in a conical fashion, whenunconstrained. In order to permit imaging of the extraction member byfluoroscopy, the plug or hub 72 may include or be made of a radio-opaquematerial. To further aid in locating the extraction member 70 within apatient by fluoroscopy, a second (or more) radio-opaque marker 75 may beseparated by a known distance L5. In an embodiment, the distance L5between approximately 0.5 inches and approximately 2 inches.

It is noted that the plug or hub 72 can be a generally tubular memberwith a central lumen to allow for passage of a guidewire, contrastagent, saline or other members to be delivered to the tips of the wires73. The couplers 74 on the tips of the plurality of wires 73 may beconfigured to increase the probability that they snare the locator andanchor members of the blood filter. To accomplish this, the couplers maybe configured as a hook having a radius R3 that is approximately 1 to 3times the diameter of the filter member wires. Further, the hooks may beoff center and/or canted at an angle to the centerline of the wires asillustrated in FIGS. 5A, 5B and 5C, to increase the probability that thehooks will snare one or more filter wires when positioned among thefilter members. Additionally, while the couplers 74 are shown asdifferent types of hooks in FIGS. 5A-5C, other forms of couplers can beused.

For example, the generally spheroidal member shown in FIG. 5D canreplace the hooks or other couplers where the outer diameter of thespheroidal member is smaller than a gap between any two adjacentlocators or anchors of the blood filter. With the spheroidal members,the withdrawal of the wires 73 will cause the spheroidal members to movetowards the longitudinal axis and come into contact with each otherwhile retaining the portions of the filter proximal of the spheroidalmembers. Moreover, another foreseeable form of the couplers can be asingle loop type, e.g., a snaring hoop shown in FIG. 5E, to capture theproximal portion (e.g., hub) of the filter and locate such portion in avolume defined by the retrieving cone.

The extraction member rod or wire 71 may be fabricated of a solid wire,bar or tube of a material, such as stainless steel, with a sufficientlyhigh modulus of elasticity to permit the extraction member 70 to bepushed through the elongated tubular member 60 and/or the catheter 50without kinking and to be rotated within the elongated tubular member 60and/or the catheter 50 without twisting or kinking. The plurality ofwires 73 may be made from a metal such as stainless steel, or morepreferably a shape memory alloy such as, for example, Nitinol preferablyhaving an austenite finish (A_(f)) temperature below body temperature.Wires 73 made from Nitinol may be annealed in the desired conicalconfiguration to establish that configuration as the wires' memoryshape. So formed, the Nitinol wires 73 may be folded into a form thatwill fit within the elongated tubular member 60 and/or catheter 50.

In use, an embodiment of the elongated tubular member 60 may be advancedwithin the catheter 50 until the conical portion 66 extends beyond thedistal end of the catheter 50, as illustrated in FIG. 6. Thus projectingfrom the catheter allows the conical portion 66 to be used to envelopthe hub of a filter making it easier to engage the filter in a bloodvessel. Also, the combination of radio-opaque markers on the conicalportion (marker 64) and on the catheter (markers 54, 55) help aclinician to position the assembly near the filter using fluoroscopy. Bycomparing the distance between the radio-opaque markers 64 on theconical portion 66 and the catheter distal end radio-opaque marker 54with the known distance between the radio-opaque markers 54, 55 on thecatheter 50, the clinician can determine with fluoroscopy when theelongated tubular member 60 has been advanced sufficiently to allow fullexpansion of the conical portion 66 and/or when the conical portion 66has encompassed the filter.

In use, an embodiment of the extraction member 70 may be advanced withinthe elongated tubular member 60 so that the plurality of wires 73 extendwithin the conical member 66 as illustrated in FIG. 7A. In analternative embodiment, the extraction member 70 may be advanced withinthe elongated tubular member 60 so that the plurality of extractionwires 73 extend beyond the conical member 66 as illustrated in FIG. 7B.

With the embodiments assembled in the configurations illustrated inFIGS. 7A and 7B, the filter extraction assembly is ready for engagingand extracting a filter. These configurations may be assembled through anumber of alternative structural and/or methods of use embodiments.Examples of these alternative structure and assembly/use methodembodiments are described below.

In one embodiment, the catheter 50 is first positioned near a filter ina blood vessel as illustrated in FIG. 8, the elongated tubular member 60is next advanced through the catheter 50 until the conical portion 66deploys as illustrated in FIG. 6, the extraction member 70 is thenadvanced through the elongated tubular member 60 until the plurality ofwires 73 extends into the conical portion 66, as illustrated in FIG. 7Aor beyond the conical portion 66, as illustrated in FIG. 7B. Thisembodiment of assembly permits a clinician to use the catheter 50 toinspect the filter prior to preparing to remove it.

In another embodiment, the extraction member 70 may be positioned withinthe elongated tubular member 60 during fabrication, so that in use, theclinician first positions the catheter 50 near a filter 1 in a vein asillustrated in FIG. 8, followed by advancing the pre-assembled elongatedtubular member 60 and extraction member 70 through the catheter 50 untilthe conical portion 66 deploys as illustrated in FIGS. 6 and 7A.Finally, the extraction member 70 may be advanced a small distance toextend the plurality of wires 73 beyond the conical portion 66 asillustrated in FIG. 7B. This embodiment facilitates advancing theextraction member 70 within the catheter 50 since the plurality of wires73 are enclosed within the conical portion 66 so they will not bind inthe catheter.

In yet another embodiment, the extraction member 70 may be positionedwithin the elongated tubular member 60 which is positioned within thecatheter 50 during fabrication as an extraction system. In thisembodiment, the extraction member 70 and elongated tubular member 60 areinitially positioned within the catheter 50. In use, the assembledextraction system is first advanced within a vein by the clinician untilit is positioned near the filter. Then the tubular member 60 andextraction member 70 are distally advanced within the catheter 50 untilthe conical portion 66 extends as illustrated in FIGS. 6 and 7A.Finally, in an embodiment, the extraction member 70 may be distallyadvanced within the elongated tubular member 60 as illustrated in FIG.7B.

Once the filter extraction assembly of one of the prior embodiments isdeployed near the filter, the plurality of wires 73 are pressed into thefilter members 20, 30 so the hooks on the wires can engage the filterlocator and/or anchor members, as illustrated in FIGS. 9 and 10A. Soengaged, the filter members can be pulled toward the centerline of thevessel and away from the wall by rotating the extraction member 70, asillustrated in FIG. 10B. Filter members 20, 30 can also be retracted byencompassing them within the conical portion 66 of the elongated tubularmember 60. This may be accomplished by holding the extraction member 70fixed while pushing the elongated tubular 60 member in a distaldirection to position the conical portion 66 around the filter,including the filter members. To collapse the conical portion 66 overfilter, the catheter 50 is pushed in the distal direction while holdingthe extended tubular member 60 and the extraction member 70 fixed. Thisis illustrated in FIGS. 11A and 11B. As the catheter 50 pushes over theconical member 66, the conical member 66 collapses inward pressingagainst the filter members 20, 30, further pulling the filter membersaway from the vessel wall. The conical portion 66 also covers the filteranchor hooks 40 so that they can be pulled into the catheter withoutcatching on the vessel wall or the catheter. Finally, the filter 1 maybe pulled fully into the catheter, as illustrated in FIG. 12, afterwhich the catheter may be withdrawn from the patient's body.

An alternative embodiment of the filter extraction assembly isillustrated in FIGS. 13-18. In this embodiment, instead of a pluralityof wires 73, one or a few extraction wires 80 coupled to the hub 72 areformed in a helical shape, preferably a conically shaped helix asillustrated in FIG. 13. When the helical extraction wire 80 ispositioned over the filter, the extraction member 70 can be rotated inthe direction of the helix, perhaps with some distal motion of theextraction member 70. As a result of this rotational motion, the helicalextraction wire 80 encircles the filter members 20, 30 in a screwfashion, drawing the filter members in toward the centerline of thehelix and toward the extraction member hub 72, thereby releasing thefilter members from the blood vessel walls and securely attaching thehelical extraction wire 80 to the filter.

In the embodiment illustrated in FIG. 13, the helical extraction wire 80is formed in a conical shape with the narrow end of the cone coupled tothe hub 72 of the extraction member 70. The conical helix shape may becharacterized by its longitudinal extension length L6 between the hub 72and the open distal end 81, its conical angle θ of the outside contour83 to the centerline 82 of the helix and extraction member 70, and thenumber of rotations about the centerline 82 (i.e., density of thehelix). This embodiment allows the extraction wire 80 to assist inpositioning the extraction assembly over a filter since the broad openend 81 will engage the filter across an area larger than the crosssection of the catheter. Rotation of the extraction wire 80 will drawthe wire and the filter into centerline alignment. With furtherrotation, the helix and filter members 20, 30 become more tightlyentangled, collapsing the extraction wire 80 about the filter so thecaptured filter can be drawn into the catheter 50.

In an alternative embodiment illustrated in FIG. 14, multiple helicalextraction wires 80A, 80B are coupled to the hub 72 of the extractionmember 70. FIG. 14 shows two helical extraction wires 80A and 80B, butthree, four or more wires may be used. Preferably, the multiple helicalwires are equiangularly offset about the centerline. For example,embodiments employing two helical wires will be rotationally oriented180 degrees one from the other, and embodiments employing three helicalwires may be rotationally oriented 120 degrees apart. Embodimentsemploying multiple helical wires 80 may more easily capture filtermembers since each rotation will pass more wires through the filtermembers 20, 30. Alternatively, the cross section of a single helicalwire can be varied to achieve different stiffness.

The embodiments illustrated in FIGS. 13-18 may utilize a catheter 50 andelongated tubular member 60 similar to those used with otherembodiments. In embodiments employing an elongated tubular member 60,the helical extraction wire 80 may be contained within the conicalportion 66, as illustrated in FIG. 15. In this configuration, theconical portion 66 will prevent the helical extraction wire 80 fromscratching or digging into the walls of the blood vessel. Also, theconical portion 66 and the helical extraction wire 80 may work incombination to position the filter near the centerline 82. Consequently,the conical angle θ of the helical extraction wire 80 may be narrow(such as between approximately parallel to the centerline toapproximately 30 degrees) since the conical portion 66 will direct thefilter and extraction wire towards each other to facilitate engaging thefilter members. In the preferred embodiment, the wire 80 utilizes anatraumatic tip (e.g., a rounded loop, soft tip, cone or sphere).

In an alternative embodiment, the conical form of the helical extractionwires 80 may permit eliminating the elongated tubular member 60 sincethe conical form of the wires may perform the filter locating functionotherwise performed by the conical portion 66. Further, as the conicalhelix 80 is rotated, the wires may draw the filter toward the hub 72 andthe filter members 20, 30 toward the centerline. In order to reveal thefunctioning of the helical extraction wire 80 this embodiment isillustrated in FIGS. 16-18.

In use, the catheter 50 is positioned near the filter 1 within a bloodvessel 10, as illustrated in FIG. 8, and the extraction member 70 isadvanced in a distal direction until the helical extraction wire 80 isclear of the distal end of the catheter 50. The extraction member 70 maybe advanced to pass the helical extraction wire 80 at least partiallyover the filter, as illustrated in FIG. 16. In this configuration, theclinician rotates the extraction member 70 by rotating a handle on theproximal end. Rotational motion causes the helical extraction wire 80 topass through the locator members 20 and anchor members 30, pulling thefilter members and the wire 80 in toward the centerline 82, asillustrated in FIG. 17. Moving the anchor members 30 toward thecenterline causes their hooks to become disengaged from the vessel walls10 without tearing the endothelial layers, including the endothelialovergrowth. Once the anchor members 30 have been pulled away from thevessel walls, the filter may be drawn into the catheter 50, asillustrated in FIG. 18, by either advancing the catheter in the distaldirection while holding the extraction member 70 in a fixed position, orpulling the extraction member 70 in the proximal direction while holdingthe catheter steady. Once the filter is pulled within the catheter, thecatheter may be withdrawn from the patient. Alternatively, theextraction member 70 is not rotated, but instead translated so that themember 70 encircles a substantial portion of the filter. Extraction ofthe filter can be obtained by moving the catheter 50 and member 70relative to each other. For example, the catheter 50 may be moveddistally away from the clinician while maintaining the extraction member70 generally stationary; the extraction member 70 and catheter 50 may bemoved toward each other; or the extraction member 70 may be movedproximally while maintaining the catheter 50 stationary. Additionally,the helical member can be formed so that its austenite transformationfinish temperature Af is greater than 37 degrees Celsius and preferablygreater than 42 degrees Celsius so that warm saline (e.g., at greaterthan 37 degrees Celsius) can be utilized to clamp the helical memberdown on the filter once the helical member is in position proximate thefilter.

In alternative embodiments illustrated in FIGS. 19A and 19B, theelongated tubular member 60 may be eliminated by coupling a flexibleconical portion 76 to the extraction member 70, such as at the distalhub or node 72. In this embodiment, the conical portion 76 may be madeof a flexible polymer material, such as polyurethane, polyethylene,polyamide, polyether block amide (PEBA), nylon, and combinationsthereof, and coupled to the hub 72 by a bio-compatible adhesive, e.g.,cyanoacrylates. The conical portion 76 may include folds or thinnedsections (such as, for example, folds 68 illustrated in FIG. 3) topermit the cone to be collapsed in order to fit into a catheter. In use,the conical portion 76 may be deployed by holding the catheter in afixed position while pushing on the proximal end of the extractionmember 70 until the distal end extends from the catheter. Once deployedfrom the catheter the conical portion 76 is pushed over the filter sothe plurality of wires 73 or the helical extraction wire 80 engage thefilter members 20, 30. By rotating the extraction member 70, the filtermembers may be pulled away from the vessel walls. At this point, theconical portion 76 may be used to encircle the filter by pushing thecatheter over the filter without moving the extraction member 70 in amanner similar to the methods of use described above.

Several design features are believed to be important in advancing thestate of the art. For example, the use of extraction wires 73, 80 toengage the filter members enables pulling the filter anchor members 30away from the vessel wall 10 before moving the filter. This is believedto help engage the filter hub 2 with the retrieving cone. Also, the useof extraction wires 73, 80 to engage the filter member enables saferemoval of a filter that is not configured (e.g., with a removal hook)to be removable. Also, the use of an extraction member with extractionwires 73, 80 to engage the filter members enables a clinician tosecurely latch onto the filter before the conical portion 66, 76 iscollapsed over the filter and is retracted into the catheter. Also, theuse of an extraction member 70 that is separate from the elongatedtubular member 60 permits the clinician to manipulate the filtergrappling wires 73, 80 separately from the conical portion 66 of thetubular member 60. Further, the use of the couplers (e.g., hooks,spheres, loops) allow for locating of the filter in the volume definedby the retrieval cone so that the cone can be utilized to collapse thefilter into a smaller configuration suitable for retrieval.

Although the preferred embodiments have been shown and described inrelation to the filter of FIG. 1, other filters can also be utilized inconjunction with the removal system described herein as long as thesefilters are collapsible to a smaller radial configuration. For example,the removal system may be provided for the filter shown and described inU.S. Pat. No. 4,425,908, which is hereby incorporated by reference inits entirety. The system may also be provided for the filter shown anddescribed in U.S. Pat. No. 6,443,972, which is also hereby incorporatedby reference in its entirety. Commercially available filters that arecollapsible may also be utilized with the filter removal systemdescribed. These commercially available filters include but are notlimited to the Greenfield® Filter, VenaTech® Filter, Gunther Tulip®Filter, TrapEase® or OptEase®.

While the present invention has been disclosed with reference to certainpreferred embodiments, numerous modifications, alterations, and changesto the described embodiments are possible without departing from thesphere and scope of the present invention. Accordingly, it is intendedthat the present invention not be limited to the described embodiments,but that it has the full scope defined by the language of the followingclaims, and equivalents thereof.

1. A blood filter and removal apparatus for removing a blood filter froma vessel wall comprising: a) a blood filter having a deployed positionwherein it is secured to a blood vessel wall, wherein in said deployedposition, the filter having a proximally positioned hub and a pluralityof distally positioned circumferentially spaced legs separated by gapsand extending distally from the hub, each leg having a vessel wallengaging hook-shaped anchor that engages the vessel wall distally of thehub in said deployed position; b) an elongate tubular member having awall with an outer surface and an inner surface, the wall surrounding alumen, a distal end portion of the tubular member being a conicalmember; c) an elongate extraction member having a distal end portionwith multiple separate, spaced apart coupler wires having differentlengths, each coupler wire having a hook, said extraction member havingan outer surface and configured to be positioned within the lumen of theelongated tubular member wherein the outer surface of the extractionmember faces the inner surface of the tubular member, the extractionmember configured to move the coupler wires longitudinally androtationally with respect to the elongate tubular member including astored position wherein said coupler wires are stored within the lumenof the elongated tubular member; d) the extraction member and filterdefining an initial leg removal position wherein the hooks of thecoupler wires are connected to the filter legs at a position that isspaced in between the hub and the leg anchors and wherein each hookenters a said gap; e) wherein in said initial leg removal position, thehooks of the coupler wires connect with the filter legs at a positionthat is spaced distally of the hub and proximally of the hook shapedanchors and the filter hook-shaped anchors configured to engage thevessel wall; f) the extraction member and filter defining a final legremoval position wherein the filter hook shaped anchors are disengagedfrom the vessel wall; g) wherein rotation of the extraction member andcoupler wires moves the filter legs from the initial leg removalposition to the final leg removal position; h) a catheter having a lumenand an inner surface that contains and closely conforms to the tubularmember, the tubular member being movable relative to the catheter andwherein the catheter inner surface is abutting the outer surface of thetubular member wall; i) the conical member collapsing as the catheterpushes over the conical member to fit within the catheter lumen and theconical member expands when extended outside the catheter lumen; j) insaid final leg removal position, the coupler wires collapse when pulledinto the conical member of the elongated tubular member and wherein thecoupler wire hooks are connected to the filter legs; and k) wherein theconical member has a radius when expanded of between about 0.25 inchesand 0.75 inches.
 2. The blood filter and removal apparatus according toclaim 1, wherein the elongate extraction member coupler wires arecoupled to the distal end of the elongated extraction member.
 3. Theblood filter and removal apparatus according to claim 1, wherein theelongate extraction member includes a generally tubular member having alumen extending therethrough.
 4. The blood filter and removal apparatusaccording to claim 1, wherein the elongate extraction member includes ahelical extraction wire.
 5. A blood filter and removal apparatus forremoving a blood filter from a vessel wall comprising: a) a blood filteradapted to be secured to a blood vessel wall, the filter having aproximally positioned hub and a plurality of distally positionedcircumferentially spaced legs separated by gaps extending distally fromthe hub, each leg having a vessel wall engaging anchor that anchors thefilter to a vessel wall in a deployed position of said filter spaceddistally of the hub wherein said legs define a first diameter; b) acatheter having a proximal end, a distal end, catheter lumen and acentral longitudinal axis; c) an elongate extraction device configuredto be positioned within the catheter lumen defining a first position,the elongate extraction device being moveable longitudinally androtationally with respect to the catheter central longitudinal axis; d)an elongated tubular member comprising an open conical member on adistal end; e) the extraction device having a plurality of wires coupledto a distal end of the elongated extraction device, each wire having adistal end with a coupler that includes a bend, the extraction devicebeing movable longitudinally relative to the open conical member and thewires being movable axially relative to the open conical member and eachwire being movable independently of the other wires; f) wherein each ofthe couplers are configured to connect with a said leg of the bloodfilter by entering a said gap distally of the hub, and proximally of thesaid anchor wherein the plurality of wires are configured to divergeapproximately conically when the plurality of wires extend beyond thedistal end of the catheter; g) wherein the extraction device wires andfilter legs define an initial leg removal position in which the couplersconnect with the legs distally of the hub and proximally of the bend andthe wall engaging anchors are anchored to the vessel wall; h) a finalleg removal position wherein the wall engaging anchors are not anchoredto the vessel wall; i) rotation of the extraction device and filter legseffecting movement from the initial leg removal position to the finalleg removal position; j) a storage position of the filter defined by thewires collapsing into the conical member of the elongated tubular memberwherein the couplers are connected to the filter legs and the legs arecollapsed to a second diameter that is smaller than said first diameter.6. The apparatus of claim 5, further comprising a handle coupled to aproximal end, and an internal lumen, the elongated tubular memberconfigured to be inserted into and moved longitudinally within thecatheter.
 7. The apparatus of claim 6, wherein the open conical memberhas a radio-opaque marker.
 8. The apparatus of claim 5, wherein eachcoupler of the plurality of couplers is configured to engage a filterleg of the blood filter when the plurality of wires are positioned amongthe filter legs.
 9. The apparatus of claim 5, wherein the extractiondevice comprises a radio-opaque marker.
 10. The apparatus of claim 5,wherein each of the plurality of couplers comprises at least one of ahook, a loop or a generally spheroidal member.
 11. A blood filterremoval system for removing a blood filter from a vessel wallcomprising: a) a blood filter configured to be located in a bloodvessel, the filter having proximal and distal ends and multiple spacedapart legs with gaps between legs, each leg having a vessel wallhook-shaped anchor that anchors the distal end of the filter to theblood vessel in a filter deployed position; b) an assembly for removingthe blood filter from the blood vessel, the assembly including acatheter having an inner surface surrounding a catheter lumen, saidlumen extending through the catheter; c) the assembly including anelongated tubular member comprising an internal tubular member lumen andan open conical member on a distal end of said tubular member, theelongated tubular member configured to be inserted into and movedlongitudinally with respect to the catheter lumen and wherein thetubular member has an outer surface that engages the catheter innersurface; d) the assembly including an elongate extraction memberconfigured to be positioned in the tubular member lumen defining astorage position, said extraction member configured to movelongitudinally and rotationally with respect to the tubular member, theextraction member having a distal end and a plurality of coupler wirescoupled to the distal end the coupler wires having different lengths; e)a plurality of hook-shaped couplers, at least one of the plurality ofhook-shaped couplers being attached to a respective one of the pluralityof coupler wires, each of the hook-shaped couplers connecting with asaid one of the legs in between the leg proximal and distal ends byentering a said gap to define an initial leg removal position whereinthe anchors are anchored to the vessel wall; f) a final leg removalposition wherein the anchors are not anchored to the vessel wall; g)wherein movement from the initial leg removal position to the final legremoval position includes rotation of the wires and couplers; h) theconical member being collapsible within the catheter when the catheterpushes over the conical member and wherein the extraction member, filterand conical member occupy the catheter lumen; and i) wherein there is notubular structure in between the catheter and the tubular member, theelongate extraction member being movable longitudinally relative to theconical member and the coupler wires being movable axially relative tothe conical member and each coupler wire being movable independently ofthe other coupler wires.
 12. The system of claim 11, wherein the bloodfilter comprises: a hub; and said wires are coupled to the hub, whereinat least a portion of the hook-shaped coupler has a cross sectionsmaller than a cross section of the coupler wire.
 13. The system ofclaim 12, wherein the blood filter further comprises a plurality oflocator members coupled to the hub, and the hub includes a radio-opaquemarker.
 14. The system of claim 11, wherein the plurality of couplerwires are configured to diverge generally conically when the extractionmember is positioned such that a portion of the plurality of wiresextend distally at the open conical member of the tubular member. 15.The system of claim 11, wherein the tubular member further comprises ahandle coupled to a proximal end, the tubular member handle configuredto permit insertion and withdrawal of the tubular member in the catheterwithout moving the catheter.
 16. The system of claim 15, wherein theextraction member further comprises a handle on a proximal end, theextraction member handle configured to permit inserting and withdrawingthe extraction member within the tubular member without moving thetubular member or the catheter.
 17. The system of claim 11, wherein theplurality of couplers are each configured to engage the filter legs ofthe blood filter when the plurality of wires are positioned among thefilter legs.
 18. The system of claim 11, wherein the conical membercomprises a radio-opaque marker.
 19. The system of claim 11, wherein theextraction member comprises a radio-opaque marker.
 20. (canceled) 21.The system of claim 11, wherein a distal end of the catheter comprises aradio-opaque marker. 22-38. (canceled)